Intravenous Oliceridine and Opioid-related Complications

  • STATUS
    Recruiting
  • End date
    Jul 15, 2025
  • participants needed
    200
  • sponsor
    The Cleveland Clinic
Updated on 25 April 2022

Summary

The investigator will evaluate the side effects of oliceridine.

Description

The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.

Details
Condition Major Surgery
Treatment Oliceridine
Clinical Study IdentifierNCT04979247
SponsorThe Cleveland Clinic
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥18 years old
American Society of Anesthesiologists physical status 1-4
Scheduled for major noncardiac surgery expected to last at least 2 hours
Expected to remain hospitalized at least two postoperative nights
Scheduled for general endotracheal, spinal anesthesia, or the combination
Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents
Expected to have patient-controlled intravenous analgesia

Exclusion Criteria

Are demented or otherwise cannot provide valid consent
Have contraindications to oliceridine
Used legal or illegal opioids chronically, defined as >15 mg morphine equivalents for >15 days during the month before consenting by history
Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring
Have planned epidural anesthesia/analgesia
Planned spinal morphine administration
Are designated Do Not Resuscitate, hospice, or receiving end of life therapy
Are expected to require postoperative mechanical ventilation or ICU admission
Are expected to receive intrathecal opioids
Are expected to receive gabapentin, pregabalin or other analgesic adjuvants
Use oxygen at home
Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula)
Are known to be pregnant or breastfeeding
Use CPAP at home
Have previously participated in the trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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